NCT00612599已完成3 期
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Non-obese and Obese With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Area under the serum glucose concentration profile during 24 hours
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 12 months
- •Stable glycaemic control, having been on the existing treatment for at least 1 month
- •BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
- •HbA1c below 9.0%
- •Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly
排除标准
- •A history of drug abuse or alcohol dependence
- •Blood donation within the last 3 months
- •Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
- •Severe, uncontrolled hypertension
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)
结局指标
主要结局
Area under the serum glucose concentration profile during 24 hours
时间窗: after 4 weeks of treatment
次要结局
- Hypoglycaemic episodes
- Pharmacokinetic properties
- 8-point self-monitored blood glucose profiles
- Pharmacodynamics properties
- Adverse events
研究者
研究点 (2)
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